نبذة مختصرة : Background: Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal.
Methods: The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12-19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members.
Discussion: Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART.
Trial Registration: ISRCTN, ISRCTN15973986 , registered on 6 September 2022; ClinicalTrials.gov, NCT05394311 , registered 27 May 2022.
(© 2023. BioMed Central Ltd., part of Springer Nature.)
References: Ross DA, Hinton R, Melles-Brewer M, Engel D, Zeck W, Fagan L, et al. Adolescent well-being: a definition and conceptual framework. J Adolesc Health. 2020;67(4):472–6. Epub 2020/08/18. https://doi.org/10.1016/j.jadohealth.2020.06.042 . PubMed PMID: 32800426; PubMed Central PMCID: PMCPMC7423586.
Clarke A, Friede T, Putz R, Ashdown J, Martin S, Blake A, et al. Warwick-Edinburgh Mental Well-being Scale (WEMWBS): validated for teenage school students in England and Scotland. A mixed methods assessment. BMC Public Health. 2011;11:487. https://doi.org/10.1186/1471-2458-11-487 .
Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008;70(7):741–56. Epub 2008/08/30. https://doi.org/10.1097/PSY.0b013e31818105ba . PubMed PMID: 18725425.
Kubzansky LD, Huffman JC, Boehm JK, Hernandez R, Kim ES, Koga HK, et al. Positive psychological well-being and cardiovascular disease. J Am Coll Cardiol. 2018;72(12):1382–96. https://doi.org/10.1016/j.jacc.2018.07.042 . (PMID: 10.1016/j.jacc.2018.07.042302133326289282)
Lasselin J, Alvarez-Salas E, Grigoleit J-S. Well-being and immune response: a multi-system perspective. Curr Opin Pharmacol. 2016;29:34–41. https://doi.org/10.1016/j.coph.2016.05.003 . (PMID: 10.1016/j.coph.2016.05.00327318753)
Blum RW, Lai J, Martinez M, Jessee C. Adolescent connectedness: cornerstone for health and wellbeing. BMJ. 2022;379:e069213. https://doi.org/10.1136/bmj-2021-069213 . (PMID: 10.1136/bmj-2021-069213363025269600165)
Vijayaraghavan J, Vidyarthi A, Livesey A, Gittings L, Levy M, Timilsina A, et al. Strengthening adolescent agency for optimal health outcomes. BMJ. 2022;379:e069484. https://doi.org/10.1136/bmj-2021-069484 . (PMID: 10.1136/bmj-2021-069484363025469600168)
Purgato M, Uphoff E, Singh R, Thapa Pachya A, Abdulmalik J, van Ginneken N. Promotion, prevention and treatment interventions for mental health in low- and middle-income countries through a task-shifting approach. Epidemiol Psychiatr Sci. 2020;29(e150):1–8.
United Nations. World Population Prospects 2017. New York: 2017.
Patel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, et al. The Lancet Commission on global mental health and sustainable development. Lancet. 2018;392(10157):1553–98. (PMID: 10.1016/S0140-6736(18)31612-X30314863)
World Health Organization. The global strategy for women’s, children’s and adolescents’ health (2016–2030): Survive, thrive, transform. 2015.
World Health Organization. Guidelines on mental health promotive and preventive interventions for adolescents: helping adolescents thrive. 2020.
Doré I, Sabiston CM, Sylvestre M-P, Brunet J, O’Loughlin J, Nader PA, et al. Years participating in sports during childhood predicts mental health in adolescence: a 5-year longitudinal study. J Adolesc Health. 2019;64(6):790–6. https://doi.org/10.1016/j.jadohealth.2018.11.024 . (PMID: 10.1016/j.jadohealth.2018.11.02431122508)
Lubans D, Richards J, Hillman C, Faulkner G, Beauchamp M, Nilsson M, et al. Physical activity for cognitive and mental health in youth: a systematic review of mechanisms. Pediatrics. 2016;138(3): e20161642. (PMID: 10.1542/peds.2016-164227542849)
Bernstein E, McNally R. Acute aerobic exercise helps overcome emotion regulation deficits. Cogn Emot. 2017. https://doi.org/10.1080/02699931.2016.1168284 . (PMID: 10.1080/02699931.2016.116828427484697)
Mansfield L, Kay T, Meads C, Grigsby-Duffy L, Lane J, John A, et al. Sport and dance interventions for healthy young people (15–24 years) to promote subjective well-being: a systematic review. BMJ Open. 2018;8(7):e020959. https://doi.org/10.1136/bmjopen-2017-020959 . (PMID: 10.1136/bmjopen-2017-020959300084446082460)
Karmaliani R, McFarlane J, Khuwaja HMA, Somani Y, Bhamani SS, Saeed Ali T, et al. Right To Play’s intervention to reduce peer violence among children in public schools in Pakistan: a cluster-randomized controlled trial. Glob Health Action. 2020;13(1):1836604. https://doi.org/10.1080/16549716.2020.1836604 . (PMID: 10.1080/16549716.2020.1836604331387407646585)
Richards J, Foster C, Townsend N, Bauman A. Physical fitness and mental health impact of a sport-for-development intervention in a post-conflict setting: randomised controlled trial nested within an observational study of adolescents in Gulu Uganda. BMC Public Health. 2014;14:619. (PMID: 10.1186/1471-2458-14-619249434724079830)
National Statistics Office. National Population and Housing Census 2021: National Report. Kathmandu: Government of Nepal; 2023.
Statistics CBo. National Population and Housing Census 2011 Kathmandu, Nepal. 2014.
Nonyane BA, KCA, Callaghan-Koru JA, Guenther T, Sitrin D, Syed U, et al. Equity improvements in maternal and newborn care indicators: results from the Bardiya district of Nepal. Health Policy Plann. 2015;31(4):405–14. https://doi.org/10.1093/heapol/czv077 .
Fottrell E, Azad K, Kuddus A, Younes L, Shaha S, Nahar T, et al. The effect of increased coverage of participatory women's groups on neonatal mortality in Bangladesh: a cluster randomized trial. JAMA Pediatr. 2013;167(9):816–25. Epub 2013/05/22. https://doi.org/10.1001/jamapediatrics.2013.2534 . PubMed PMID: 23689475; PubMed Central PMCID: PMCPMC5082727.
Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, Tumbahangphe KM, et al. Effect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet. 2004;364(9438):970–9. Epub 2004/09/15. https://doi.org/10.1016/s0140-6736(04)17021-9 . PubMed PMID: 15364188.
Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, et al. Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial. Lancet. 2010;375(9721):1182–92. (PMID: 10.1016/S0140-6736(09)62042-020207411)
Bhatia K, Rath S, Pradhan H, Samal S, Copas A, Gagrai S, et al. Effects of community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India (JIAH trial): a cluster-randomised controlled trial. SSM – Popul Health. 2023;21:101330. https://doi.org/10.1016/j.ssmph.2022.101330 .
Kingsbury M, Clayborne Z, Colman I, Kirkbride JB. The protective effect of neighbourhood social cohesion on adolescent mental health following stressful life events. Psychological Medicine. 2020;50(8):1292–9. Epub 2019/06/10. https://doi.org/10.1017/S0033291719001235 .
Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, et al. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016;387(10036):2423–78. https://doi.org/10.1016/S0140-6736(16)00579-1 . (PMID: 10.1016/S0140-6736(16)00579-1271743045832967)
World Health Organization. mhGAP Humanitarian Intervention Guide (mhGAP-HIG): Clinical management of mental, neurological and substance use conditions in humanitarian emergencies. Geneva: WHO; 2015.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5(1):63. https://doi.org/10.1186/1477-7525-5-63 . (PMID: 10.1186/1477-7525-5-63180423002222612)
Rosenberg M. Society and the adolescent self-image. Princeton: Princeton University Press; 1965. (PMID: 10.1515/9781400876136)
Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in health psychology: a user’s portfolio causal and control beliefs. Windsor: NFER-NELSON; 1995. p. 35–7.
Zhou X, Hetrick SE, Cuijpers P, Qin B, Barth J, Whittington CJ, et al. Comparative efficacy and acceptability of psychotherapies for depression in children and adolescents: a systematic review and network meta-analysis. World Psychiatry. 2015;14(2):207–22 (PubMed PMID: 26043339). (PMID: 10.1002/wps.20217260433394471978)
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The Multidimensional Scale of Perceived Social Support. J Pers Assess. 1988;52(1):30–41. https://doi.org/10.1207/s15327752jpa5201_2 . (PMID: 10.1207/s15327752jpa5201_2)
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7. (PMID: 10.1001/archinte.166.10.109216717171)
Johnson JG, Harris ES, Spitzer RL, Williams JBW. The patient health questionnaire for adolescents: Validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002;30(3):196–204. (PMID: 10.1016/S1054-139X(01)00333-011869927)
Affairs UDoEaS. World Population Prospects: The 2019 Revision. 2019.
Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM. How big should the pilot study for my cluster randomised trial be? Stat Methods Med Res. 2016;25(3):1039–56. https://doi.org/10.1177/0962280215588242 . (PubMed PMID: 26071431). (PMID: 10.1177/096228021558824226071431)
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. https://doi.org/10.1186/1471-2288-13-117 . (PMID: 10.1186/1471-2288-13-117240472043848812)
Vuchinich S, Flay BR, Aber L, Bickman L. Person mobility in the design and analysis of cluster-randomized cohort prevention trials. Prev Sci. 2012;13(3):300–13. https://doi.org/10.1007/s11121-011-0265-y . (PMID: 10.1007/s11121-011-0265-y22249907)
Balzer LB, van der Laan M, Ayieko J, Kamya M, Chamie G, Schwab J, et al. Two-Stage TMLE to reduce bias and improve efficiency in cluster randomized trials. Biostatistics. 2021. https://doi.org/10.1093/biostatistics/kxab043 . (PMID: 10.1093/biostatistics/kxab04310102904)
Leech NL, Onwuegbuzie AJ. A typology of mixed methods research designs. Qual Quant. 2009;43(2):265–75. https://doi.org/10.1007/s11135-007-9105-3 . (PMID: 10.1007/s11135-007-9105-3)
O’cathain A, Murphy E, Nicholl J. The quality of mixed methods studies in health services research. J Health Serv Res Policy. 2008;13(2):92–8. https://doi.org/10.1258/jhsrp.2007.007074 . (PubMed PMID: 18416914). (PMID: 10.1258/jhsrp.2007.00707418416914)
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